|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02799173 |
|
Date of registration:
|
10/06/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
CALCILUP |
|
Scientific title:
|
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification |
|
Date of first enrolment:
|
April 15, 2011 |
|
Target sample size:
|
74 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02799173 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Cécile MAZIERE, Md, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU Amiens |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Women over 18 years old
- suffering from systemic lupus erythematosus.
Exclusion Criteria:
underlying diseases that can lead to bone and cardiovascular metabolic disturbances :
- Malignancies such as cancer metastasized
- Autoimmune disease other than LED or of overlap syndrome ( rhupus , MCTD )
- Infection by HIV, hepatitis B and C
- Hepatic Cirrhosis
- Chronic renal failure
- Parathyroid disorders
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Lupus Erythematosus, Systemic
|
|
Osteoporosis
|
|
Intervention(s)
|
|
Device: fan beam CT scan
|
|
Biological: RANKL/OPG ratio
|
|
Device: Doppler ultrasound
|
|
Device: bone densitometry
|
|
Primary Outcome(s)
|
|
presence of osteoporosis
[Time Frame: Day 0]
|
|
RANKL/OPG ratio
[Time Frame: Day 0]
|
|
Secondary ID(s)
|
|
PHRCIR09-PR-MAZIERE-MME
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|